A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

Neoplasm Metastasis Clinical Trial

Official title:

Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728390
• Other study ID #: A7471004
• Status: Completed
• Phase: Phase 1
• Start date: December 15, 2008
• Est. completion date: January 29, 2013

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 29, 2013
• Est. primary completion date: August 9, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;

• Platelets > 100,000, ANC > 1500;

• Ccr > 60 or serum creat. <1.5

• Non-small cell cancer cohort:

• Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen

• HgA1C <5.7%

Exclusion Criteria:

• Active Central Nervous System (CNS) metastases;

• prior IGF1-R targeted therapy

• Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell
• Neoplasm Metastasis

Intervention

Drug:
• PF-00299804
CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Villejuif
Spain	Pfizer Investigational Site	Madrid
United States	Pfizer Investigational Site	Amherst	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities.		18 months
Secondary	Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871		12 months
Secondary	Progression Free Survival (PFS)		15 months
Secondary	Best overall response (OR) defined according to RECIST guidelines.		12 months
Secondary	Duration of response (DR)		15 months
Secondary	Anti-Drug Antibodies (ADA) response;		18 months
Secondary	KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort		12 months

External Links

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